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A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures

This study has been terminated.
(Change in business priorities.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01100190
First Posted: April 8, 2010
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ethicon, Inc.
April 7, 2010
April 8, 2010
August 11, 2017
March 1, 2010
April 1, 2011   (Final data collection date for primary outcome measure)
Composite incidence of adverse device events [ Time Frame: up to 30-days post-procedure ]
The primary tolerability endpoint includes sensory nerve injury, skin necrosis, wound dehiscence, hypertrophic scarring, alopecia, surgical site infection, earlobe deformity, submental irregularity, hematomas, perforation, and palpability.
Not Provided
Complete list of historical versions of study NCT01100190 on ClinicalTrials.gov Archive Site
  • Individual incidence of adverse device events [ Time Frame: up to 3 yrs post-op ]
  • Incidence of treatment failures and cosmetic re-intervention [ Time Frame: up to 3 yrs post-op ]
  • Quality of Life changes prior to and after surgery [ Time Frame: up to 3 yrs post-op ]
  • Global Improvement Assessment using standardized photographic images [ Time Frame: up to 3 yrs post-op ]
Not Provided
Not Provided
Not Provided
 
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.
This is a multicenter, prospective, single-arm study. The primary tolerability endpoint will be evaluated up to 30-days post-operatively. Secondary endpoints will be evaluated at 6-months. Extended follow-up will be conducted at 12-months, 24-months, and 36-months.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ptosis of the Neck, Mid-face and/or Jowl
Device: NUVANCE Facial Rejuvenation System
The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.
Experimental: NUVANCE Facial Rejuvenation System
Intervention: Device: NUVANCE Facial Rejuvenation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
March 1, 2014
April 1, 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subject older than 18 years.
  • Subject is a candidate for minimally invasive, bilateral facial rejuvenation procedure using NUVANCETM Facial Rejuvenation System according to the device Instructions for Use (IFU).
  • Subject is willing and able to provide informed consent and follow study-related requirements.

Exclusion Criteria:

  • Subject who previously received surgical facial cosmetic treatment (procedure involving an incision):

    1. Within the last 12 months under the area of the forehead;
    2. Within the last 3 months within the area of the forehead where forehead is defined as the area above the imaginary anatomical line between the lateral canthus of the eye and the upper pole of the ear.
  • Subject who previously received a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within the last 9 months.
  • Subjects with a permanent facial implant.
  • Subjects planning on a cosmetic procedure with a permanent implant within 6-months of procedure.
  • Subjects planning on a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within 6-months of procedure.
  • Subjects with significant ptosis where skin excision would be necessary.
  • Subject has an active infection (e.g. acne, herpes zoster) or inflammation (e.g. psoriasis, pemphigus vulgaris, cutaneous lupus erythematosus) affecting facial skin.
  • Subject has a history of a disorder that can affect wound healing (e.g. subjects pre-disposed to infection or history of keloid formation).
  • Subject with pre-existing facial abnormalities (e.g. deformities, Bell's palsy, scarring)
  • Subject with a significant psychiatric disorder judged by the clinical investigator that will interfere with the procedure
  • Any pre-operative findings that the surgeon identifies that makes the subject not a candidate for a minimally invasive facial cosmetic surgical procedure.
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Israel,   United Kingdom
 
 
NCT01100190
200-08-001
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Not an applicable trial, product manufactured outside of US and all study sites outside US.
Ethicon, Inc.
Ethicon, Inc.
Not Provided
Study Director: Martin Weisberg, MD Ethicon, Inc.
Ethicon, Inc.
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP